Compositions for the prevention and treatment of cutaneous affections

Abstract

A pharmaceutical composition is described for the prevention and treatment of external otitis or otitis media, in particular in the veterinary field. The composition of the invention comprises a synergistic association of N-acetylcysteine and a stabilizing agent, which has been shown to be significantly active against pathogens causing the external otitis, at the same time significantly reducing the disadvantages of N-acetylcysteine.

1 . A pharmaceutical composition comprising N-acetylcysteine and a stabilizing agent, wherein said stabilizing agent comprises
 a buffer compound selected from TRIS (or tris(hydroxymethyl) aminomethane), PIPES (or piperazin-1,4-bis(2-ethanesulfonate acid)), TRIS*HCl, HEPES (or 4-2-hydroxyethyl-1-piperazinyl-ethanesulfonic acid), monobasic and dibasic sodium phosphate, or citric acid, and   a sequestering compound selected from EGTA (ethyleneglycoltetraacetic acid), EDTA (ethylenediaminetetraacetic acid) or its salified anhydrous or hydrated form, calcium-disodium EDTA or its hydrated form, diammonium EDTA or its hydrated form, bipotassium EDTA or its hydrated form, bisodium EDTA or its hydrated or dihydrated form, TEA-EDTA (EDTA mono salt (triethanolamine)), tetrasodium EDTA, tripotassium EDTA, trisodium EDTA, HEDTA (hydroxyethyl-ethylenediaminotriacetic acid), HEDTA-EDTA, and mixtures thereof,   said stabilizing agent is in a quantity higher than N-acetylcysteine, and   said composition has a pH of 7-9 in water.   
     
     
         2 . The composition of  claim 1 , wherein stabilizing agent and N-acetylcysteine are in a weight ratio of at least 1.2:1. 
     
     
         3 . The composition of  claim 1 , wherein stabilizing agent and N-acetylcysteine are in a weight ratio of 1.5:1 to 20:1. 
     
     
         4 . The composition of  claim 1 , wherein, in the stabilizing agent, said buffer compound is in a quantity higher than said sequestering compound. 
     
     
         5 . The composition of  claim 4 , wherein said buffer compound and said sequestering compound are in a weight ratio of 1.1:1 to 20:1. 
     
     
         6 . The composition of  claim 1 , comprising up to 10 wt % of stabilizing agent, based on the weight of the composition. 
     
     
         7 . The composition of  claim 6 , comprising up to 8 wt % of stabilizing agent, based on the weight of the composition. 
     
     
         8 . The composition of  claim 1 , comprising N-acetylcysteine, TRIS, disodium EDTA, and water. 
     
     
         9 . The composition of  claim 1 , comprising up to 5 wt % of N-acetylcysteine, based on the weight of the composition. 
     
     
         10 . A method of treating cutaneous affections and external otitis and otitis media, said method comprising the step of administering by external topical route to a subject in need thereof the composition of  claim 1 , wherein said subject is an animal.